Global Clinical Supply Chain Operations Manager
7 days ago
We are seeking an experienced Senior Project Manager, Global Clinical Supply Chain Strategist to join our team at Genmab. As a key member of our Global Clinical Drug Supply Planning, Operations & Systems team, you will play a critical role in leading and supporting the planning and maintenance of supplies for clinical trials.
Key Responsibilities- Develop and maintain integrated project plans and technical blueprints that consolidate project schedules, resources, and budgets.
- Monitor and control project integration to ensure successful project execution and delivery.
- Facilitate effective communication and collaboration between cross-functional stakeholders and project teams to ensure project alignment and integration.
- Identify and manage project dependencies and potential conflicts to ensure seamless project execution.
- Develop and maintain global processes for Global Drug Clinical Supply Strategy & Integration.
- Collaborate with stakeholders to ensure process and procedures flows are maintained for the clinical supply stakeholders, cross-functional team, and regional teams.
- Lead the development and implementation of process improvements and digital solutions.
- Ensure process optimization, compliance, and sustainability.
- Provide training, guidance, and support for process improvements and other continuous improvement efforts.
- Align, continuously, processes with evolving business requirements, goals, and strategic changes, while providing inputs to risk management.
- Develop innovation goals, prioritization, and operational/projects plans for global clinical drug supplies in partnership with R&D Teams and enabling functions.
- Optimize end-to-end supply operations across therapeutic areas and remove bottlenecks.
- Track and forecast resource capacity, utilization, and allocation in collaboration with global clinical drug supply.
- Establish and maintain financial transparency for all projects, trials, and initiatives, while identifying ways to reduce cost and overall waste of supplies and resources.
- Track key performance indicators (KPIs) to measure performance and implement corrective and preventative actions.
- Monitor and manage the performance of external service providers.
- Assess and mitigate operational risks and ensure compliance with regulations and internal processes.
- Identify areas for improvement and implement changes to enhance efficiency, productivity, and quality.
- Foster a culture of continuous improvement and innovation.
- Maintain a deep understanding of continuous improvement, development strategy, risk management, and industry trends to drive informed decision-making.
- Create and maintain program/project plans, trial IMP/AxMP forecast and demand plans, and budgets throughout the trial lifecycle.
- Maintain all project/program trial level inventory and ensuring no stock out situations.
- Lead and participate in cross functional teams and support strategic cross functional collaboration (i.e., project/program and trials).
- Lead Clinical Project Supply Team discussions.
- Participate in regulatory discussions in relation to IMP/AxMP.
- Manage project/trial specific planning documentation (i.e., drug supply plan, milestone tracking, IMP manual, etc.).
- Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, and deliverables.
- Support inspection and audit preparation and execution.
- Supervise, train, and educate colleagues in Global Clinical Drug Supply, drive and support trouble shooting in trials/projects and risk mitigate for operational items.
- Language ability – Advanced Proficiency in speaking and writing in Chinese (Simplified).
- Minimum of a completed Master's degree with +8 years of experience, or completed PhD degree with +6 year of experience.
- Experience in handling integration management, process and continuous improvement management, digital or data technology, operations, supply chain, manufacturing, ERP, clinical supply chain, logistics, preferably in the pharmaceutical or biopharmaceutical industry.
- Broad and Diverse experience in working with trial management for global clinical drug supply and supply functions.
- Knowledge and understanding of GMP, GDP, and GCP. Supply Chain systems and processes.
- Strong desire to exploit emerging technologies for better business outcomes.
- Proven experience working in teams.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
- Ability to be proactive, enthusiastic, and goal orientated.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.
- Strong communication skills in English - both oral and written.
- Ability to travel to China periodically if necessary (preferred but not required).
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